Joint MHRA/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing
This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.
It is also possible to register for each of the 4 course modules separately:
Module 1: Definitions and Methods in Pharmacovigilance
Module 2: Regulatory Aspects in Pharmacovigilance and Practical Examples
Module 3: Signal Detection and Management
Module 4: Risk Management
"Very well organized course that covered the basics of PV. Materials seemed good but I did not use them during the lectures because most of the presentations were interactive and the faculty was presenting their topics very well."
Martti Ahtola, PV Network Coordinator, European Pharminvent Services
"Very valuable! Useful insight of both regulator/ industry perspective & good cover across all areas of PV. Case studies & interactive examples were great to enhance understanding."
What you will learn
Definitions and Methods in Pharmacovigilance
Regulatory Aspects in Pharmacovigilance and Practical Examples
Diagnosis of Adverse Drug Reactions
Signal Detection and Signal Management
Modern Technologies and Social Media
Who should attend?
For the five key topics as outlined above, the learning objectives also include the ability to:
Describe the expedited and periodic ICSRs reporting requirements in clinical trials and post-marketing including the medical evaluation
Understand the process of audits and inspections in pharmacovigilance
Understand the principles of signal management
Describe the components of the risk management
Gaby L. Danan, DIAFellow, MD, PhD • Pharmacovigilance Expert
Phil Tregunno • Signal Management Unit Manager
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom